Side Effects of Vaccines

10 Key excerpts on "Side Effects of Vaccines"

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  eBook - ePub

  Vaccines For Dummies

  • Megan Coffee, Sharon Perkins(Authors)
  • 2021(Publication Date)
  • For Dummies

    (Publisher)

  While vaccine side effects do occur, they’re mostly more of a nuisance than a serious problem. Some side effects are common. Others are less common and specific to certain vaccines. Rarely, some side effects can pose a serious health risk. In this chapter, you get the scoop on common side effects, serious reactions, and the effect of many vaccines on the immune system.

  Sometimes what seems like a side effect is actually just an unrelated health problem. Vaccines protect us from specific diseases but don’t protect us from everything out there. We can still have new health problems. This is especially true when vaccinating those who are elderly or very young as well as those with weakened immune systems. Sometimes we can just have bad luck after being vaccinated. In one of the COVID-19 vaccine trials, one adverse event that occurred after vaccination was that someone was hit by lightning. No one thinks the vaccine caused that.

  Understanding Side Effects: What May Cause Them and What Happens

  Over 1 billion vaccines are given worldwide each year. For most people, the side effects are minimal and the benefits have been life-saving. But sometimes your immune system reacts when it sees something new, and this reaction can cause you to have side effects. In some cases, this is a good thing; it shows your immune system is working well.

  You should react in some way to a foreign object in your body. In the same way that your skin might turn red or irritated around a splinter, your arm can react to an injection with common symptoms, such as redness or swelling. Some of the materials in vaccines can cause temporary irritation. The actual vaccine material itself can cause your immune system to react with more systemic, or body-wide, symptoms. The following sections give you the basics on vaccine side effects.

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  New Generation Vaccines

  • Myrone M. Levine, Myron M. Levine, Gordon Dougan, Michael F. Good, Margaret A. Liu, Gary J. Nabel, James P. Nataro, Rino Rappuoli, Myrone M. Levine, Myron M. Levine, Gordon Dougan, Michael F. Good, Gary J. Nabel, James P. Nataro, Rino Rappuoli, Myrone M. Levine, Myron M. Levine, Gordon Dougan, Michael F. Good, Gary J. Nabel, James P. Nataro, Rino Rappuoli(Authors)
  • 2016(Publication Date)
  • CRC Press

    (Publisher)

  14 Vaccine Safety a Neal A. Halsey Department of International Health, Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, U.S.A. Robert Ball Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, Maryland, U.S.A. Leslie K. Ball Center for Drug Evaluation and Research, Rockville, Maryland, U.S.A. INTRODUCTION The benefits of immunization in reducing the morbidity and mortality of infectious diseases are well recognized from both public health and individual perspectives. Widespread use of vaccines in the past century led to eradication of smallpox and control of many infectious diseases including diphtheria, per-tussis, measles, and polio (1). These public health triumphs, however, come with the implicit understanding that immuni-zations are not completely free of risk. Vaccines, like all pharmaceutical products, can have adverse effects ranging from transient common local reactions to rare but serious and irreversible events. Vaccines are held to higher safety standards than drugs because they are usually given to healthy individ-uals (often children) to prevent an infectious disease rather than to treat an established disease or condition. Also, many vac-cines are required for children to attend school in the United States and other countries. Vaccine developers need to construct a comprehensive plan for incorporating vaccine safety throughout the life cycle of the vaccine from preclinical testing through post-marketing. In each phase of the life cycle, different strategies and tools are needed to monitor safety and identify problems as quickly as possible. In this chapter, we review how vaccines cause adverse events, lessons learned from historical events and recent con-troversies, describe scientific methods for evaluating the safety of vaccines, and review principles of risk management and risk communication for immunization safety.

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  Drug Hypersensitivity

  • W. J. Pichler, Pichler(Authors)
  • 2007(Publication Date)
  • S. Karger

    (Publisher)

  Adverse Side Effects to Biological Agents 155 General Principle of Adverse Effects of Biological Agents In a recent review of adverse reactions of biologi-cal agents, Lee and Kavanaugh differentiated be-tween target-related or agent-related adverse side effects [10]. Indeed, target-related side effects are common with biological agents, as for example a biological agent may alter the composition and functional integrity of the normal immune re-sponse, and thereby predispose the patient to cer-tain side effects, while the agent itself is rather ‘harmless’: Consequently, to understand the great variety of adverse side effects of biological agents, one has to be aware not only of the activity of the biological agent for the particular disease, but also of its influence on the normal immune bal-ance. (a) Many biological agents have a well-defined range of physiological actions [8], some of which may already explain some adverse ‘side’ effects. For example, it is expectable that high concentra-tions of a proinflammatory cytokine like IFN- can cause symptoms which are also observed during an immune reaction with high IFN- lev-els (e.g. flu-like syndrome). (b) Biological agents often affect T and B cells or their products, as well as the different effector cells leading to various forms of inflammation. Side effects of biological agents affecting the im-mune response are to a certain degree predictable and consequently cannot be classified as unpre-dictable ‘type B’ reactions [3]. A question in the same line is: Can a hypersensitivity reaction to an injected protein, which contains parts of a for-eign protein, be classified as an unpredictable type B reaction, or is it not actually a predictable reaction, even if it does not occur in each indi-vidual? (c) Immunological reactions during therapy with small molecular compounds (drugs) are mainly classified as hypersensitivity reactions [5, 6].

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  Stephens' Detection of New Adverse Drug Reactions

  • John Talbot, Patrick Waller, John Talbot, Patrick Waller(Authors)
  • 2004(Publication Date)
  • Wiley

    (Publisher)

  schooling, and ensuring that national vaccine compensation schemes are available for those who have been damaged as a result of immunization without requiring recourse to litigation. The provision of readily accessible, authoritative and evidence-based information on the risks of the disease and of the vaccine underpins these approaches. All these factors make it essential that the systems responsible for safety surveillance are as robust as possible and are accompanied by equally robust systems for surveillance of vaccine-preventable infections. Pathogenesis of vaccine reactions Direct effects As with any pharmaceutical product, adverse events from a vaccine may arise as a result of a toxic or other direct effect of one of its components. With inactivated bacterial vaccines, the inclusion of endo- or exo-toxins can result in a local inflammatory reaction at the injection site or a systemic effect such as fever. A typical example of an endotoxin-mediated adverse effect is that seen with whole pertussis vaccines (Baraff et al., 1989). Exotoxin- mediated effects are exemplified by anthrax vaccine, which consists of a cell-free filtrate of Bacillus anthracis, containing various amounts of exotoxins such as oedema and lethal factor (Brachman and Freidlander, 1999). Such toxin-mediated effects, usually occur within 24 h of immunization and resolve within a day or two. The effect of subsequent doses is difficult to predict; for example, endotoxin-mediated adverse effects are often age depen- dent, with an increase in reactogenicity with age. On the other hand, generation of antibody responses to vaccine toxins may result in a decrease in reactogenicity with subsequent doses. With live vaccines, adverse events can result from the replication of the attenuated vaccine strain, the clinical picture resembling, albeit in a milder form, that seen with the wild infection.

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  Stephens' Detection and Evaluation of Adverse Drug Reactions

  Principles and Practice

  • John Talbot, Jeffrey K. Aronson, John Talbot, Jeffrey K. Aronson(Authors)
  • 2011(Publication Date)
  • Wiley-Blackwell

    (Publisher)

  Here we review the pathogenesis of adverse reactions to vaccines and the methods available for the detection and investigation of safety concerns. However, in order to make an informed decision about the benefit-harm profile of an immunization programme, information on the efficacy of a vaccine and its impact in reducing the burden of disease at the population level is required. Hence, it is essential that the national systems responsible for safety surveillance are accompanied by equally robust systems for surveillance of vaccine-preventable infections.

  13.3 Pathogenesis of vaccine reactions 13.3.1 Direct effects

  As with any pharmaceutical product, adverse reactions from a vaccine may arise as a result of an adverse effect of any of its components. With inactivated bacterial vaccines, the inclusion of endotoxins or exotoxins can result in a local inflammatory reaction at the injection site or a systemic effect such as fever. A typical example of an endotoxin-mediated adverse effect is that seen with whole pertussis vaccines [4]. Exotoxin-mediated effects are exemplified by anthrax vaccine, which consists of a cell-free filtrate of Bacillus anthracis , containing various amounts of poorly characterized exotoxins, which produce characteristic effects in animal models [5]. Such toxin-mediated effects, usually occur within 24 hours of immunization and resolve within a day or two. The effect of subsequent doses is difficult to predict; for example, endotoxin-mediated adverse effects often increase with age. On the other hand, generation of antibody responses to vaccine toxins may result in reduced reactogenicity with subsequent doses.

  With live vaccines, adverse reactions can result from replication of the attenuated vaccine strain, the clinical picture resembling, albeit in a milder form, that seen with the wild infection. For example, attenuated measles vaccine produces a mild fever in about a quarter of children at around 7–12 days after immunization, caused by the viraemia that occurs when vaccine virus replicates in the body [6]. As expected, such effects are smaller with subsequent doses, as the induction of immunity prevents viral replication. On rare occasions, the direct pathological effect of a live viral vaccine may be severe, as with the aseptic meningitis seen with some mumps vaccine strains (for example Urabe); identification of vaccine virus in the cerebrospinal fluid (CSF) [7], together with a statistically significantly increased risk of aseptic meningitis in the immediate post-vaccination period [8], have confirmed a causal relation to immunization. Other examples of serious reactions that are directly attributable to the pathogenic effects of the live organisms in a vaccine are acute flaccid paralysis from oral poliomyelitis vaccine (OPV) and the disseminated infection seen in immunocompromised individuals given bacille Calmette–Guérin (BCG) vaccine.

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  Vaccine Supply and Innovation

  • (Author)
  • 0(Publication Date)
  • The National Academies Press

    (Publisher)

  5 Vaccine Injury The occurrence of adverse reactions to vaccines raises numerous questions of the magnitude of risk to the individual compared with overall benefits to the population, of how to protect those at increased risk, of the potential for vaccine improvement, of appropriate compensation for injuries, and of the effects of vaccine-related injury liability on vaccine production and utilization. The first section of this chapter focuses on the factors that impede efforts to establish cause-and-effect relationships in cases of vaccine-related injury, and the problem of determining the true frequencies of adverse effects among vaccinees. The second section consists of a review of scientific data on major adverse reactions to commonly used domestic vaccines for children and adults. Chapter 6 examines the legal ramifications of vaccine injury and compensation issues, and the effect of the current state of the law on vaccine production and innovation. The mechanisms most likely to ensure rapid identification of vaccine-related injuries and improved coordination of vaccine improvement efforts are discussed more fully in Chapter 7. Adverse reactions have been attributed to various vaccines for many years, but until recently few scientifically acceptable efforts have been made to determine the frequency of these events. One reason for this situation is that many of the diseases for which effective vaccines have been developed were so feared by the public and the medical community that at first the side effects of immunization were ignored or accepted as a necessary evil. Fifty years ago, when an estimated 2 million or more cases of whooping cough with 7,000 deaths occurred annually in the United States, little attention was paid to the rare infant who displayed severe symptoms following inoculation with the newly developed vaccine.

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  Adverse Effects of Vaccines: Evidence and Causality

  • (Author)
  • 0(Publication Date)
  • The National Academies Press

    (Publisher)

  The best-understood vaccine-associated adverse effect is the occurrence of invasive disease (such as meningoencephalitis and arthritis) caused by the vaccine virus itself in individuals with an acquired or genetic immuno- deficiency who receive live vaccines such as VZV, MMR, and oral polio vaccine. Although the incidence of such infections may decrease with the introduction of newborn screening for severe combined immunodeficiency, the occurrence of vaccine-related disease can be the trigger that leads to the recognition of immunodeficiency (Galea et al., 2008; Ghaffar et al., 2000; Kramer et al., 2001; Levy et al., 2003). Invasive disease may also occur by viral reactivation in individuals who previously received these vaccines while healthy, but who subsequently become immunocompromised, for example, as a result of chemotherapy should they later develop cancer or leukemia (Chan et al., 2007; Levin et al., 2003). Not all individuals who suffer invasive disease have demonstrated recognized immune deficien- cies, even when vaccine virus is recovered from the patient (Iyer et al., Adverse Effects of Vaccines: Evidence and Causality Copyright National Academy of Sciences. All rights reserved. EVALUATING BIOLOGICAL MECHANISMS OF ADVERSE EVENTS 83 2009; Levin et al., 2008). This leads to two hypotheses: either immuno- competent individuals can acquire invasive disease from vaccine virus, or further evaluation of these patients would reveal previously unrecognized immunodeficiencies. Many adverse events appear to be immune-mediated. Anaphylaxis is an obvious example of this. In some patients who experience anaphylaxis, the triggering antigen can be identified with follow-up testing. Known trigger- ing antigens include egg and gelatin. But even when the triggering antigen such as egg or gelatin is known, it is not clear why some people develop anaphylaxis while the vast majority does not.

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  The Vaccine Book

  • Barry R. Bloom, Barry R. Bloom, Paul-Henri Lambert(Authors)
  • 2002(Publication Date)
  • Academic Press

    (Publisher)

  8

  VACCINE SAFETY: REAL AND PERCEIVED ISSUES

  NEALA. HALSEY,     Institute for Vaccine Safety, Johns Hopkins University, Baltimore, Maryland 21205

  I. INTRODUCTION

  Vaccines are the most effective tools available for the prevention and control of infectious diseases. Widespread use of vaccines has prevented millions of premature deaths, paralysis, blindness, and neurological damage. Nevertheless, since the smallpox vaccine was developed more than 200 years ago, vaccines have been controversial because of concerns about safety. Vaccines, which are administered to healthy people, are held to a higher safety standard than medications to treat people who are already ill, and vaccines are often given universally to infants and children so that even a very low risk of serious side effects can result in a substantial population-attributable risk.

  The tolerance for adverse events associated with vaccines varies because of real and perceived differences in the risks and severity of the illness prevented. Increased public awareness of product safety has led to decreased tolerance for vaccine-associated adverse events. As with air and highway travel, food products, and toys, advocacy groups argue for increased attention to the safety of medications and vaccines. When infections such as measles, diphtheria, and polio were common in our society, it was easier to accept occasional rare serious side effects from vaccines as a necessary risk. As immunization programs have become more successful and the risk of contracting preventable diseases has diminished, the acceptance of side effects from immunizations has also decreased.

  Smallpox vaccine caused several serious adverse events, including eczema vaccinatum, encephalitis, and progressive debilitating infections in patients with immunodeficiency disorders [1 ]. When the risk of smallpox diminished to near zero in the United States, the acceptance of these serious adverse events decreased, and routine immunization against smallpox ended in 1972, 6 years prior to the interruption of transmission of smallpox in Africa [2

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  Vaccines for Veterinarians E-Book

  • Ian R Tizard, Ian R. Tizard(Authors)
  • 2019(Publication Date)
  • Elsevier

    (Publisher)

  Chapter 10

  Adverse consequences of vaccination

  Outline

  • Adverse Events
  • Hypersensitivity Responses
  • Residual Virulence
  • Other Issues
  • Errors in Manufacture and Administration
  • Human Illness
  • Reporting

  Vaccination is the only safe, reliable, and effective way of protecting animals against the major infectious diseases. Society does not remember the devastating toll taken by infectious diseases before the development of modern vaccines. Exaggerated fear of negative side effects has discouraged owners from having their pets (and themselves) from being vaccinated. The rise of the Internet and the development of social media have enabled those who oppose vaccination to spread their opinions. Those who resist vaccination for themselves or their children are unlikely to be enthusiastic about vaccinating their pets. Much of this resistance is a result of adverse events and controversy regarding effectiveness associated with the earliest vaccines. In spite of the fact that these problems have long been solved, it takes a considerable time before confidence is restored. There is a lack of awareness of the rigorous safety tests that modern vaccines must undergo before they are marketed. Good manufacturing practices and the quality control procedures used by the biologics industry, together with rigorous regulatory controls, serve to minimize the occurrence of these events. Past issues have been corrected and vaccine safety has steadily improved. Modern vaccines are safe to use and overwhelmingly beneficial. Adverse events associated with vaccination that might compromise the health of an animal are usually rare, mild, and transient. Hypothetical, speculative, or historical adverse effects sometimes dominate perceptions. Nevertheless, it has been truly said, “The most dangerous vaccine is the one not given.” In reading this chapter the reader should be aware that the events described here are rare, somewhat historical, and relatively unimportant when compared with the benefits of vaccination.

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  A New History of Vaccines for Infectious Diseases

  Immunization - Chance and Necessity

  • Anthony R. Rees, Anthony Robert Rees(Authors)
  • 2022(Publication Date)
  • Academic Press

    (Publisher)

  Chapter 15: Vaccines are not always perfect: adverse effects and their clinical impact

  Abstract

  The nature of vaccines and the dichotomy of public opinion about their efficacy, and often the ethical debates about how they are produced, is not new phenomena. Antivaccination movements were present at the end of the 19th century and have existed in every decade, with every new vaccine, ever since. This chapter explores the origins and reasons for vaccination reluctance, sometimes medically justified, mostly based on fallacious scientific argument, and sometimes as a result of pure prejudice against government intervention in the individual’s freedom. In some cases, vaccine prejudice has been justified where vaccinees have suffered adverse effects (AEs) that have been said to be directly due to the vaccine itself, and rarely, thank goodness, to manufacturing errors that have clearly caused such effects. The analysis of the possible contributions to any observed AE, monitored by clinical trial procedures, due to manufacturing additives and adjuvants present within the vaccine sample itself, are described. The results of expert analysis of the likelihood of “cause and effect” for such AEs is described, and the improvements in vaccine technology today, particularly the immunity enhancing adjuvants, that minimize the possibility of a vaccine component’s contribution to postvaccination ill effects are reviewed. Finally, the issue of vaccine safety, of some of the concerns raised with COVID19 vaccines, and the history of cause and effect arguments for those vaccines are discussed.

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